High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT02860039|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2016
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic Cell Transplantation Recipient Malignant Neoplasm Influenza||Biological: Trivalent Influenza Vaccine Biological: Quadrivalent Influenza Vaccine Other: Laboratory Biomarker Analysis||Phase 2|
I. To determine whether high-dose trivalent inactivated influenza vaccine (HD-TIV) compared with standard dose quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a >= 4-fold rise in hemagglutination-inhibition (HAI) titers, >= 1:40 HAI titer, or higher geometric mean titer (GMT) to influenza A antigens in pediatric hematopoietic stem cell transplant (HSCT) recipients.
I. To determine whether HD-TIV compared with standard dose QIV will increase the probability of achieving a >= 4-fold rise in HAI titers, >= 1:40 HAI titer, or higher GMT titers to influenza B antigens in pediatric HSCT recipients.
II. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/ tenderness, redness, and swelling at injection site) with HD-TIV compared to standard QIV in pediatric HSCT recipients.
III. To determine the frequency and severity of solicited systemic adverse events (e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting) with HD-TIV compared to standard dose QIV in pediatric HSCT recipients.
IV. To define the relationship between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell response in pediatric HSCT recipients receiving either HD-TIV or standard dose QIV.
V. To correlate HAI responses to microneutralization responses.
VI. To compare the persistent HAI and microneutralization (MN) titers for all four antigen seven months after the last vaccine dose to assess for persistence of antibody titers.
VII. To compare influenza detection by PCR during influenza season in pediatric HSCT recipients receiving either HD-TIV or standard dose QIV.
VIII. To assess HAI and MN response in children vaccinated during year 1 and revaccinated during year 2 using the same antigen dose.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP I (Experimental): Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.
GROUP II (Standard): Patients receive standard dose QIV IM on day 0 and day 28.
After completion of study treatment, patients are followed up at 28-42 days, and at 7 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||January 2022|
Experimental: Group 1 - High Dose HD-TIV
Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.
Biological: Trivalent Influenza Vaccine
High dose Trivalent Influenza Vaccine given intramuscular
Other: Laboratory Biomarker Analysis
Active Comparator: Group 2 - Standard Dose QIV
Patients receive standard dose QIV IM on day 0 and day 28.
Biological: Quadrivalent Influenza Vaccine
Standard dose Quadrivalent Influenza Vaccine given intramuscular
Other: Laboratory Biomarker Analysis
- Immunogenicity as measured by the number of subjects who achieve a 4-fold (or greater) rise in post-vaccination HAI titers [ Time Frame: Baseline up to 7 months after the second vaccination ]
- Incidence and severity of solicited local injection site adverse events [ Time Frame: Up to 7 days following each vaccination ]
- T and B cell phenotype assessed by mass cytometry [ Time Frame: Up to 7 months after second vaccination ]
- T and B cell response assessed by mass cytometry and in-vitro functionality assays [ Time Frame: Up to 7 months after second vaccination ]
- Percentage of individuals in each group who test positive for influenza [ Time Frame: During the influenza season, up to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860039
|United States, California|
|UCSF Children's Hospital|
|San Francisco, California, United States, 94158|
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|United States, Ohio|
|Cincinnati Children's Hospital|
|Cincinnati, Ohio, United States, 45229|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Children's Hospital Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Natasha Halasa, MD, MPH||Vanderbilt University|